This is a prospective, open-label, randomized controlled trial involving 80 adult patients with newly diagnosed T2DM (diagnosed within the last 3 months) recruited at the Bogomolets National Medical University. Participants may be lifestyle-controlled or receiving stable non-insulin anti-diabetic medications. Participants will be randomized in a 1:1 ratio to either the Real-Time Continuous Glucose Monitoring group (CGM group) or the control group (standard Self-Monitoring of Blood Glucose \[SMBG\] using conventional glucometers).
The gathered data will help determine whether the real-time visual feedback provided by CGM systems superiorly improves glycemic variability, optimizes metabolic parameters, and enhances patient adherence to lifestyle interventions and pharmacological treatment compared to conventional SMBG methods in the early stages of T2D.
Age of 18 years and older.
Newly diagnosed Type 2 Diabetes Mellitus according to ADA (American Diabetes Association) criteria (Fasting Plasma Glucose ≥ 7.0 mmol/L, or 2-hour Post-Prandial Glucose ≥ 11.1 mmol/L during OGTT, or HbA1c ≥6.5%).
Time since the initial diagnosis of T2D must not exceed 3 months ( less 90 days) at the time of screening.
HbA1c level between 6.5% and 9.5% (inclusive) at screening.
Diagnosis or suspicion of Type 1 Diabetes, Latent Autoimmune Diabetes in Adults (LADA) (e.g., positive anti-GAD antibodies if tested), or secondary types of diabetes (e.g., pancreatic or drug-induced).
Any prior or current use of insulin therapy.
Severe microvascular or macrovascular complications (proliferative retinopathy, severe diabetic nephropathy with eGFR < 45 mL/min/1.73m², diabetic foot ulcers, severe peripheral neuropathy).
Endocrine disorders (e.g., Itsenko-Cushing syndrome, acromegaly) that affect glycemia.
Parallel
CGM Sibionics
DeviceA registered medical device for real-time monitoring of glucose levels in interstitial fluid.
On-Call Extra Glucometer
DeviceCapillary glucose monitoring using fingerstick glucometer as per standard care.
Changes in HbA1c level
HbA1c in percent
Changes in Fructosamine level
Fructosamine in μmol/L
Homeostatic Model Assessment of Insulin Resistance (HOMA2-IR)
HOMA2-IR will be calculated based on fasting plasma glucose and fasting serum insulin levels using the non-linear Homeostasis Model Assessment. The score is continuous, theoretically starting from 0, where higher values indicate greater insulin resistance (a worse clinical outcome).
insulin sensitivity (%S)
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism
β-cell function (%B)
This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism
body mass index (BMI)
weight in kg and height in meters will be combined to report BMI in kg/m\^2
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Nazarii Kobyliak
Lead sponsor
Bogomolets National Medical University
Sponsor institution
COR-Medical LLC
Collaborator
Iridium LLC
Collaborator
